Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Janssen Pharmaceutical Sciences Unlimited Company
Patriot Pharmaceuticals, LLC
985639841
Janssen Pharmaceutica, NV
Patriot Pharmaceuticals, LLC
370005019
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
itraconazole
Product Details
NDC Product Code
10147-0150Application Number
NDA020657Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 16, 2023ADRABETADEXInactive
Code: 8W6Q67R6NXClass: IACTQuantity: 400 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
CHERRYInactive
Code: BUC5I9595WClass: IACT
CARAMELInactive
Code: T9D99G2B1RClass: IACT
ItraconazoleActive
Code: 304NUG5GF4Class: ACTIBQuantity: 10 mg in 1 mL